Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 10:58 PM
Ignite Modification Date: 2025-12-25 @ 8:26 PM
NCT ID: NCT03491969
Description: None
Frequency Threshold: 0
Time Frame: 2 years
Study: NCT03491969
Study Brief: Clinical Study of Lipoic Acid on Ischemic Heart Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Alpha-Lipoic Acid(α-LA) Double blind treatment period consisted of treatment with CHF standard treatments, followed by α-LA 200 mg tid over a total duration of 24 months. Alpha-Lipoic Acid(α-LA): 200 mg, po, tid 32 None 12 145 31 145 View
Placebo Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months. Placebos: 200 mg, po, tid 40 None 14 144 25 144 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization for Worsened heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization for stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hospitalization for fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hospitalization for arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastrointestinal symptoms NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Worsened renal function SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View